Leading Bioanalytical Research Institute to Open New Advanced Regulatory Analysis Center

The Barnett Institute of Chemical and Biological Analysis at Northeastern University has received a generous leadership gift from Louis Barnett B’44, H’77, and his family. The $3 million donation includes a $1 million challenge grant from the family whose 1983 endowment gift is responsible for the name of the internationally recognized research Institute. The gift will help launch the new Center for Advanced Regulatory Analysis (CARA), including the GMP/GLP (Good Manufacturing Practices/Good Laboratory Practices) Regulatory Laboratory.

Devised in collaboration with leaders of the biotechnology industry, CARA will play a critical role in ensuring drug safety and quality for all consumers by being a center that focuses on the regulatory analysis of biotechnology products, including biosimilars, and will serve as a resource to those pharmaceutical companies developing new drugs. The GMP/GLP Regulatory Laboratory will validate methods developed in the research arm, as well as conduct regulatory analysis.

“We are grateful to the Barnett family for their on-going support of the pioneering endeavors of the institute. They are helping us launch a new initiative that has enormous implications for human health and well-being,” said Joseph E. Aoun, President of Northeastern University.

Louis and Madlyn Barnett, who live in Fort Worth, Texas, have been enthusiastic supporters of the Barnett Institute, along with their three children, Laurie, Rhoda and Eliot. Laurie and Eliot, who sit on the Institute’s strategic advisory board, emphasized their father’s devotion to scientific research and the family’s commitment to the Barnett Institute under the leadership of its director, Professor Barry Karger, by saying, “This donation is a way for us to show our continued support of the institute and, more important, show our father that we support his dreams as the institute moves forward for many years to come.”

Louis Barnett, a longtime friend and colleague of Dr. Karger, refers to the Barnett Institute as his “pride and joy” for representing the future of research and leading-edge technology. “Anything that Dr. Karger suggests to me is a good thing to fund. He is one of the leading people in his field in the world,” said the philanthropist, whose career started with helping develop some of the first plastic polymers at General Electric and later went on to founding one of the largest independent houseware-products businesses in the U.S.

“We are trying to advance the science of regulatory analysis and we wouldn’t be where we are without the Barnetts’ generous financial support,” said Professor Barry Karger, Director of the Barnett Institute of Chemical and Biological Analysis at Northeastern. “One of the most important things we can do is come up with creative ways of interacting with industry, government, and health-care institutions.”

With the recent fatalities associated with heparin making national headlines, there is a looming crisis in comprehensively determining the composition of biological agents used as drugs. The need for independent oversight that combines regulatory as well as cutting-edge research expertise is crucial in a time when $20 billion worth of protein pharmaceuticals will be off-patent in two years, opening the door to complex biosimilars that must be carefully analyzed and regulated.

The efforts of the new center are expected to have a global impact on the biotechnology industry. CARA will develop first-rate drug-analysis methods by working to produce new instruments for use in regulatory environments and by training scientists in the latest techniques.

Working closely with Robert Garnick, PhD ’77, retired Senior Vice President for Regulatory, Quality and Compliance Affairs at Genentech, and several other key alumni from the biotechnology industry, CARA researchers will assess whether new chemical analysis technologies using different instruments, different labs and different operators can be successfully validated as sound methods.

In addition to considering opening a training academy to reach as many workers as possible, the Center will also

- provide independent analyses of drugs produced in the U.S. and overseas

- hold joint workshops with the FDA to discuss new technologies

- develop training and accreditation standards for regulatory workers

Celebrating its 35th anniversary, the Barnett Institute is Northeastern’s oldest and most successful research center, recognized worldwide as one of the leading academic centers for the analysis and characterization of proteins. Boasting an endowment of $9 million, with external funding nearing $7 million annually, and almost a thousand published papers and seventy patents, the Institute’s expertise in separation science, mass spectrometry, and NMR and trace analysis for the study of proteins and related substances provides a strong foundation for evaluation and characterization of protein drugs and biosimilars. As an academic center, the Barnett Institute is free from commercial bias, providing a unique ability to collaborate with regulatory authorities in the development of validated technologies.

For more information, please contact Renata Nyul at 617-373-7424 or at r.nyul@neu.edu.

About The Barnett Institute at Northeastern University

The Barnett Institute at Northeastern University is recognized internationally as one of the premier centers for cutting-edge research and advanced training in analytical chemistry for biomedical applications. Established in 1973, the Institute’s close ties to the medical community and industry in Boston and beyond, along with its active program of licensing technology, provides for many “real life” applications of research advances which have led to innumerable published papers and 70 patents. Bioanalytical research is at the interface of biology, medicine, informatics and chemistry. Students and staff in the Institute are trained to think analytically and to understand the complexity of biological samples. The Institute's entrepreneurial approach and commitment to excellence has trained over 300 students to become leaders in industry and academia worldwide.

About Northeastern

Founded in 1898, Northeastern University is a private research university located in the heart of Boston. Northeastern is a leader in interdisciplinary research, urban engagement, and the integration of classroom learning with real-world experience. The university’s distinctive cooperative education program, where students alternate semesters of full-time study with semesters of paid work in fields relevant to their professional interests and major, is one of the largest and most innovative in the world. The University offers a comprehensive range of undergraduate and graduate programs leading to degrees through the doctorate in six undergraduate colleges, eight graduate schools, and two part-time divisions. For more information, please visit www.northeastern.edu.